510(k) Report

Devices descending from K121275

13 later devices reach Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222740Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…Speciality Fibres and Materials, Ltd.20240—
+1K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…Huizhou Foryou Medical Devices Co., Ltd.20222—
+1K173844Titan Ag 200Specialty Fibres and Materials, Ltd.20181—
+1K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberConvatec Limited20184—
+1K172570ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd.20182—
+1K160379Exufiber Ag+Molnlycke Health Care Us, LLC20160—
+2K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…Qingdao Bright Moon Biomedical Materials Co., Ltd.20250—
+2K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…Huizhou Foryou Medical Devices Co., Ltd.20240—
+2K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S…Foshan United Medical Technologies, Ltd.20240—
+2K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…Coloplast Corp.20240—
+2K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…Huizhou Foryou Medical Devices Co., Ltd.20240—
+2K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd.20230—
+2K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20200—